Urethral catheterless radical prostatectomy

ABSTRACT

A method and device for facilitating the anastomotic healing of a patient after a radical prostatectomy surgical procedure, without a urethral catheter, comprising the steps of performing a radical prostatectomy, fixedly positioning a splinting element between the urethra and the bladder, across the urethral opening, placing the splinting element during the performing of the radical prostatectomy and prior to surgical closure. The fixed positioning is effected from a position within the bladder with anchoring the splinting element in position relative to the interior of the bladder, setting a separate urine drainage tube, and removing the splinting element, after anastomotic healing, with a retrieval element on the splinting element or with dissolving of the splinting element.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of Ser. No. 13/541,277 filed Jul. 3,2012, which is a divisional of U.S. application Ser. No. 12/355,807filed on Jan. 19, 2009, now U.S. Pat. No. 8,241,310, the disclosure ofwhich is hereby incorporated by reference in its entirety.

FIELD OF THE INVENTION

This invention relates to procedures for performing radicalprostatectomy and post operative anastomotic healing and particularly tosplinting procedures not involving urethral catheters in roboticprocedures.

BACKGROUND OF THE INVENTION

Radical prostatectomy involves a rejoining of bladder to urethra and acatheter for 1-3 weeks. If the new joint is not splinted with a catheterit will close due to scarring. Additionally urine needs an outlet(provided by the catheter).

Radical prostatectomy is the most common oncological procedure performedby urologists and leaving an indwelling urethral catheter is consideredmandatory after open or laparoscopic radical prostatectomy to allowanastomotic healing. The duration of catheterization averages about 5-7days in most minimally invasive series. However, urinary catheterizationis a source of infection, discomfort, anxiety and embarrassment to thepatient undergoing radical prostatectomy. Definitive morbidity, such asdiscomfort, bacteriuria and urethral stricture, is also directlyassociated with the time a catheter is left in place after surgery.

There have been no published clinical trials of radical prostatectomyperformed without a urethral catheter. In gynecological and vascularprocedures, a suprapubic catheter has been shown to be better than aurethral catheter. In a review of 5 randomized control trials comparingsuprapubic catheter and urethral catheter in colorectal surgery it wasdemonstrated that patients with a suprapubic catheter experienced lesspain and discomfort than the urethral group and the suprapubic catheterwas preferred by those patients who had experience with both. Inaddition the ability to attempt normal voiding is enhanced with thelater. There is also evidence to suggest that suprapubic catheters arebetter than indwelling urethral catheters in term of bacteriuria, needfor re-catheterization and discomfort. The risk of developingbacteriuria from a catheter increases by 3-6% per day with the urethralcatheter. This would mean that by 7 to 10 days the risk would increaseto 50%.

Suprapubic catheterization is a standard procedure performed routinelyin urological practice for other indications. The anticipated adverseevents include blocked catheter, slippage and displacement of catheter.Displacement is a rare event and can be remedied simply by placing aurethral catheter with no consequences to the final result.

Other problems associated with indwelling urethral catheters includeencrustation of the catheter, bladder spasms resulting in urinaryleakage, hematuria and urethritis. A suprapubic tube is morepatient-friendly, with no risk of urethral damage. Bladder spasms occurless frequently and suprapubic tubes are generally more sanitary. Theymay also cause fewer urinary tract infections than standard urethralcatheters. Thus the benefits of the suprapubic route are reducedinfection, control and monitoring of return of normal voiding, reducedneed to recatheterize, avoidance of possible urethral damage andimproved patient satisfaction. Drainage tubes using the suprapubic routehowever have a major drawback since this alternative to a urethralcatheter does not splint the anastomosis, thus increasing the risk ofbladder neck contracture.

Postoperative urethral catheterization is often a source of majordiscomfort and pain to the patient and may cause more concern to thepatient than the procedure itself. Less invasive robotic radicalprostatectomy has emerged as a commonly utilized surgical procedure inthe management of clinically localized prostate cancer. Patientschoosing this procedure are usually driven by its cosmetic benefits,earlier continence, shorter recovery time and minimal blood loss.However, despite the smaller incisions, early ambulation and shorterhospital stay, a few patients, especially the younger ones, continue tocomplain about the urethral Foley catheter remaining in place forextended time periods. Patients tend to experience urethral discomfort,penile tip pain and meatal encrustation and irritation due to theindwelling catheter. Despite postoperative recovery being essentiallyuneventful and smooth, patients continue to focus on the catheter andcomplain—“I wish you did not have to place a urethral catheter . . . .”

SUMMARY OF THE INVENTION

It is accordingly an object of the present invention to avoid using aurethral catheter in prostatectomy procedures without compromising thetime tested principle of splinting the anastomosis in the initial fewdays following robotic prostatectomy and the minimization of thepotential for complications which can occur following urethralcatheterization such as urethral stricture, meatal stenosis, urethritisand ascending urethral bacterial colonization.

It is a further object of the present invention to provide aprostatectomy procedure which provides an alternative to the postsurgical catheter which a) splints the anastomosis and prevents theformation of cross synechia and b) drains the bladder, without the needfor a tube coming out through the penis.

It is a still further object of the present invention to provide aprocedure with improvements over the suprapubic catheter wherebysplinting of the anastomosis is effected as well.

In accordance with the present invention the prostatectomy procedure isfollowed by the placement positioning of a short splinting element suchas a small flexible tube with a closed outer end or a solid plug ofstructural rigidity (hereinafter, referred to collectively as a“splinting tube”) across the urethral opening, without significantfurther extension, in order to splint it open to prevent stricture andbladder neck contracture. The splinting tube, contrary to the normallyused urethral catheter, does not permit urine drainage therethrough, butis used in conjunction with a separate drainage tube such as asuprapubic catheter.

The splinting tube is readily placed in position, with minimal steps ortraumatization, by a forceps in the bladder during the prostatectomyprocedure. The tube is configured to have a larger diameter than theurethral opening to provide a frictional resistance to accidentaldislodgement by urinal pressure and is preferably about 30 to 35 mm inlength. It is also preferably provided with a diameter comparable tothat of the urethral catheter (generally about 5 to 10 mm). It isdesirable that the tube or plug have a degree of flexibility for it toconform to the walls of the urethral opening to provide and maintain asnug fit and seal to prevent urine leakage. Placement of the splintingtube or plug requires no trans-urethral movement nor does it require asuprapubic placement procedure. It is desirable that the tube or plug beprovided with anchoring means such as a suture connection with thebladder or with the use of integral wing elements at an inner endthereof. These expedients prevent or retard expulsion of the tube orplug as a result of built up urine pressure. The tube or plug isprovided with removal means whereby it is removed from the urethralopening after the usual 5-7 day anastomotic healing time. Removal may beeffected by utilizing a suture material which dissolves in situ afterseven days and/or by the partial or full dissolving of the tube or plug.

The closed or outer end of the tube is preferably connected or tied to aline member which is snaked through the urethra such as by a Foleycatheter during other procedures. After the seven days of healing theline member of the splinting tube is externally pulled to disconnect thetube or plug from any anchoring suture and the tube or plug is removedthrough the urethra. In order to facilitate removal, the tube or plughas an outer diameter no larger than a urethral catheter and is removedin a manner similar to removal of a urethral catheter through theurethra. A line member may not be necessary with self dissolving tubesor plugs which automatically provide the requisite opening in thebladder leading to the urethra.

Generally the present invention comprises a method for facilitating theanastomotic healing of a patient after a radical prostatectomy surgicalprocedure, without a urethral catheter, comprising the steps of:

-   -   a) performing a radical prostatectomy,    -   b) fixedly positioning a splinting element such, as a closed end        tube or solid plug between the urethra and the bladder, across        the urethral opening,    -   c) placement of the splinting element is effected during the        performing of the radical prostatectomy and prior to surgical        closure, the fixed positioning being effected from a position        within the bladder.    -   d) anchoring the splinting element in position such as by        suturing the inner end of the anchor to the interior of the        bladder or by use or expanding wing elements,    -   e) setting a separate urine drainage tube or suprapubic        catheter,    -   f) removing the splinting element after seven days by dissolving        or absorption of the suture anchor or deflation of the wing        elements and by physical removal of the splinting element        through the urethra.

The separate urine drainage tube further contains a valve opening andclosing mechanism whereby the valve retains urine within the bladderprior to desired evacuation. The valve further comprises an activationcontrol outside of the body.

The above and other features, advantage of the present invention willbecome more evident from the following discussion and drawings in which:

SHORT DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic cross sectional view of a bladder during aprostatectomy and placement of a splinting tube of the present inventionand the position of a separate urine drainage tube, and

FIG. 2 is a second embodiment of the splinting tube with anchoringwings.

FIG. 3 shows a cross-sectional view of an embodiment of the splintingelement.

DETAILED DESCRIPTION OF THE INVENTION AND DRAWINGS

In accordance with the present invention the discomfort, pain andembarrassment of a urethral catheter is effectively eliminated by thecombination of a drainage tube or suprapubic catheter commonly utilizedfor fluid drainage, in combination with a separate splinting element.The splinting element is emplaced with fixed anchoring suturing withoutadditional surgery, during the prostatectomy procedure with forcepsalready within the bladder for the prostatectomy. Preferably, thedrainage tube is positioned at the same time as well.

The material of the splinting element is preferably comprised of aninert material and the connecting sutures which anchor the splintingelement to the bladder are of bioabsorbable materials such as used withdrug eluting stents, MUSE, and antibiotic coatings used for penileprosthesis. The splinting element is made with structural integrity andthe ability to resist stricture forces exerted thereon. The splintingelement or tube is dimensioned and positioned to form a liquid tightexternal seal at the urethral opening and is closed ended to preventexternal urinary leakage. The splinting element is preferably comprisedof inert flexible materials such as of latex or silicone. Removal of thesplinting element is effected by absorption of the anchoring sutureswithin the body after the seven day healing period. A retrieval line isattached to the tube, preferably to the closed end. At the appropriatetime, the line, which is thin and extended through the urethra withminimal discomfort, is pulled to remove the splinting tube from thesuturing anchor and to draw it from the urethral opening and through theurethra for full removal.

A hollow, close ended tube is preferred for the splinting element sincethe hollow can readily retain anchoring knotting of the removing line(which insures that the line does not disengage from the tube duringwithdrawal of the splinting device). In addition, a hollow tube providesfor greater control and minimized. Solid tubes made of appropriatematerials may however also be used in the effecting of anastomotichealing. An appropriate tube size is one with a diameter of about 5-10mm (a bevel gradation in diameter may facilitate initial placement) anda length of about 30-35 mm. Though more difficult to work with thanhollow tubes, the solid cylindrical configuration may also be used withappropriate connection of the retrieval line to the solid material. Asuturing line to the interior of the bladder is used to anchor thesplinting elements from being dislodged as a result of urine pressure.The same urine pressure however eliminates any need for preventing thesplinting element from being dislodged inwardly. Alternatively, thesplinting element itself may be comprised of a bio-absorbable ordissolving material which results, in time, with automatic self removal,without the necessity of a retrieval line.

In another embodiment a splinting element with wing elements may be usedanchor the splinting element in place, with the wings preventing outwarddislodgement. The wings are sutured to the inner walls of the bladder,with bio-absorable sutures.

There are several theoretical advantages of the approach of the presentinvention including early ambulation and reduced risk of urethralstricture. Use of a conventional urethral catheter is painful duringfirst few days and often moves with the thigh movement. This movementcauses more pain at the penis and may possibly be an impediment forearly ambulation. All the patients with the catheterless approach of thepresent invention did not have penile pain and were quite ambulatoryfollowing surgery. This early ambulation may pay many dividends in termsof reduced risk for deep vein thrombosis and enhanced overall sense ofwell being. It was discovered that the most significant benefitsincluded less penile tip and shaft pain and less discomfort in thepostoperative period as compared to the standard method. The patientshad earlier return to a normal functional status and earlier return tonormal activity.

The device in the procedure of the present invention serves two purposesa) to splint the anastomosis and b) to divert urine. In order to avoidthe urethral route, several custom made prototypes were tried in humancadaveric experiments which entered the bladder anteriorly and had adistal elongated splint to bridge the anastomosis. The final prototypehad a suprapubic drainage tube with a retention mechanism, drainageholes for diverting urine from the bladder and a distal splinting tip tokeep the anastomosis patent. This tube was easy to deploy during surgeryand to remove after 7 days.

EXAMPLE

A pilot study was undertaken for the procedure and device of the presentinvention involving a total of 30 patients (10 subjects and 20controls), who completed 6 months follow-up.

This was a prospective, non-randomized pilot study to evaluate thefeasibility of the urethral catheterless technique in patientsundergoing robotic prostatectomy. Over a period of three month, thefeasibility of the urethral catheterless approach was tested in 10patients who specifically requested this modification and signed aninformed consent. The data were compared with 20 contemporary patientswho did not undergo this modification.

Eligibility criteria—Patients with early prostate cancer who werescheduled to undergo robotic prostatectomy were candidates for thisprocedure. Patients who had large prostate volumes (>75 cc), medianlobe, high body mass index (>30), high risk cancers (Gleason-8, 9 and10, clinical stage T3 and beyond) and patients with relatively abnormalcoagulation parameters were excluded from this pilot study.

Preoperative, intraoperative and postoperative data were collectedprospectively. The duration of the catheterization was 7 days in all 30patients.

The study was used to: 1) evaluate the technique of urethralcatheterless robotic radical prostatectomy using this modification, 2)to compare the immediate outcome of the catheterless approach with thestandard technique of robotic prostatectomy in terms of discomfort,pain, penile tip irritation, need for urethral catheterization and clotretention, 3) evaluate early urinary continence between two groups and4) measure the incidence of 6 month bladder neck contracture rates.

Preoperative, intraoperative and postoperative data were collectedprospectively. The duration of the catheterization was 7 days in all 30patients.

Outcomes Measurement:

Demographic, laboratory, oncological, intraoperative and outcomes datawere measured and entered in an IRB approved database. Urethral symptomswere recorded using a specifically developed questionnaire. Thequestionnaire comprised 12 questions pertaining to a) pain at suprapubicsite, in penile shaft and penile tip, testicular pain and use of painmedications; b) discomfort while walking and sleeping c) fever; d)erosion/encrustation at tip of penis; e) bladder spasms.

Additional 3^(rd) party telephone interviews were conducted at 10, 14,21 and 30 days to determine early continence status. Patients wereconsidered continent if they were either using 0 pad or 1 security linerduring stressful activities. International Prostate Symptom Scores(IPSS) were obtained preoperatively and at 1, 3 and 6 monthspostoperatively.

Technique of Robotic Prostatectomy:

All patients underwent the athermal trizonal nerve sparing technique ofrobotic prostatectomy with total reconstruction of the continencemechanism. The continence preservation technique involves seven keyelements: (i) Preservation of the puboprostatic ligaments and arcustendineus; (ii) Creation of a muscular flap behind the bladder neck(which is later sutured to the distal end of Denonvilliers' fasciabehind the sphincter); (iii) Control of the dorsal venous complex usinga puboprostatic ligament sparing suture which also provides anteriorsuspension; (iv) Preparation of a thick and long urethral stump duringapical dissection; (v) The ‘Pagano principle’, reinforcing of the flapbehind the bladder neck; (vi) The ‘Rocco principle’, suturing of theretrotrigonal flap to the distal end of Denonvilliers' fascia, close tothe urethral stump, to prevent caudal retraction of the central tendon,thus providing posterior support; and (vii) Re-attachment of the arcustendineus and puboprostatic plate to the bladder neck after anastomosisis completed.

Technique of Deployment of Device and Anastomosis:

Urethrovesical anastomosis was performed in multiple layers using two3-0 monocryl sutures on a RB needle. Once the two posterior layers ofanastomosis were completed, (Rocco stitch followed by posterior bladder)the device was introduced through a suprapubic puncture made underdirect vision and entered the bladder 2-3 inches proximal to the bladderneck and advanced the distal attached tip of the device through theanastomosis. It took 2-3 minutes to complete this phase of the surgeryand the anterior anastomosis was completed in two layers (bladderfollowed by reconstruction of the puboprostatic-arcus tendineuscomplex).

Post Operative Care:

On the 7^(th) day, the suprapubic device was removed following acystogram. The degree of pain, discomfort and bother were assessed by aself administered questionnaire.

Statistical Analysis:

The data were entered into an Excel spreadsheet and the chi-square testand Student t test were applied to compare the group characteristics aswell as the incidence of complications between the groups, with criticalvalues and statistical significance at P<0.05.

Results:

Group 1 was the study group of 10 patients in whom robotic radicalprostatectomy was performed using catheter less approach. Group 2comprised of 20 age, tumor stage, and prostate volume matched patientsundergoing the conventional urethral catheterization technique performedin same time period. The two groups were also comparable in terms ofconsole times, amount of bleeding, or volume of blood transfusion (0),anastomotic leakage (0) and post operative retention rates (0) (P>0.05).In Group 1 which was the study group of 10 subjects, we used a custommade suprapubic catheter which provided a small anastomotic splint, twoballoons to prevent either upward or downward migration, multiple holesfor drainage and the ability to retract the splint to give a voidingtrial before removing the drainage device. Group 2 was the control groupof 20 patients in whom standard urethral catheterization was performedwith an 18F Silastic Foley catheter. Demographic, intraoperative andoutcomes data were measured and entered in an IRB approved database.Urethral symptoms were recorded using a specially developedquestionnaire.

These values are shown in Table 1.

TABLE 1 Baseline, intraoperative and post operative outcomes in twomatched cohorts MEAN (RANGE) GROUP 2 GROUP 1 (N = 20) (N = 10) URETHRALCATHETER CATHETER P VARIABLES LESS COHORT VALUE BASELINE PARAMETERS AGE60.76 (52.8-67.3) 59.99 (55.8-66.3) NS BMI 26.10 (22.9-33.2)  27.25(23.08-34.16) NS Serum (PSA) ng/ml 4.2 (2-6.8)    5.5 (3.2-12.1) NS IPSSProstate Volume ml Biopsy Gleason NS score 2-6 8 8 7 (3 + 4) 2 2 7 (4 +3) — — 8-10 — — Clinical stage NS T1b — — T1c 9 9 T2a 1 1 T2b — — T3INTRA- NS OPERATIVE PARAMETERS Estimated Blood 170  155  NS loss (cc)Console time in  80 (52-108)  78 (46-110) NS minutes Extra time for  3(2-5) — NS procedure (minutes) Intraoperative blood Nil Nil NStransfusion POST OPERATIVE NS PARAMETERS Pathological Stage NS T2a 1 2T2b 1 — T2c 7 8 T3a 1 — Duration of 7 7 NS catheterization or deviceremoval (days) Clinical urinary leak Nil Nil NS Post operative Nil NilNS retention Bladder neck Nil Nil NS contracture

As is seen in the table 2, most patients achieved continence in 6-12weeks. The catheter-less group had a greater percentage of patients whobecame continent almost immediately, however this was not statisticallysignificant (50% v/s 20% p=0.09).

TABLE 2 Continence outcomes in two cohorts of patients (0 pad status)Group 1 Group 2 P Zero pad status N = 10 N = 20 value Continence within1 6 (50%)  4 (20%) <0.5 week Continence within 6 10 (100%) 16 (80%) NSweeks Continence within 12 10 (100%) 18 (98%) NS weeks

Table 3 summarizes data regarding pain, discomfort and early ambulation.No patient in group 1 had pain in penile shaft or tip as compared to18/20 patients in group 2. (p<0.05)). 2 patients in group 1 complainedof minimal pain at the suprapubic puncture site. 2 patients in group 1had discomfort walking and sleeping as compared to 14 patients in group2 (p<0.05) and 3 patients in group 1 had bladder spasms compared to 8patients in group 2. No patient either group had hematuria or clotretention requiring irrigation. No patient in either group had symptomssuggestive of a bladder neck contracture at 6 months follow-up.

TABLE 3 Pain and discomfort outcomes Group 1 Group 2 P n = 10 n = 20value Pain at site of 2 18 <0.5 Suprapubic catheter or penile shaft Painat tip of 0 10 <0.5 penis Erosion at penile 0 5 <0.5 tip Discomfort 2 14<0.5 walking and sleepingConclusions:

Urethral catheterless robotic radical prostatectomy is feasible. Theadvantages are decreased penile shaft and tip pain and decreased patientdiscomfort and an earlier return of continence. In this pilot studythere was no late term complication such as bladder neck contracture.

Results:

The two groups were comparable in terms of age, serum prostate specificantigen (PSA) values, body mass index (BMI), Gleason scores, tumorstage, operating time, amount of bleeding, console times, anastomoticleakage and post operative retention rates. The study group hadsignificantly less penile shaft or tip pain and discomfort duringwalking or sleeping. No patient in either group had hematuria or clotretention requiring irrigation.

With reference to the drawings, In FIG. 1, the interior of bladder 10,is shown during a robotic prostatectomy procedure. Laparoscopicallyinserted forceps 20 carry and position splinting element 30, shown as atube formed of medical grade latex with a closed forward end 30 a and aremoval string 31 sutured to the forward end 30 a. The inner or distalend 30 b (or an extension thereof as shown) is provided with suturematerial 32. Forceps 20 position the splinting element 30 across theanatomotic opening 11 between the bladder 10 and the urethra 12.

The removal string 31 is snaked through the urethra for external accesswhen necessary for removal of the splinting tube. During surgery a Foleycatheter is placed through the urethra 12 to assist in anastomosis. Atthe end, before anastomotic stitches are tied, the Foley catheter ispulled outside through the anterior gap in anastomosis and string 31 istied through the tip of the Foley catheter. The Foley catheter is pulledout (with string) and the string then protrudes outside the urethra.Splinting element 30 is positioned across the anastomosis and is securedusing a 4-O Chromic catgut to the bladder wall (which dissolves over netfew days). Anastomosis is closed once a suprapubic catheter 40 isproperly positioned.

Suture material 32 is sutured to an internal wall of the bladder toanchor the splinting element 30, once positioned. The separatesuprapubic drainage catheter 40 is positioned through a wall of thebladder 10 for urine drainage.

The splinting element with integral anchoring members is shown in FIG.2. The splinting element 33 is provided with wing elements 34 a and 34 bwhich are used with the suture material 32. The wing elements 34 a and34 b engage the bladder wall, peripheral to the bladder opening toprovide an anchor for the splinting element 33. The splinting element 33is removed by the dissolving of the sutures holding the wing element 34a and 34 b and by pulling the splinting element through the urethra withthe string 31 as in the first embodiment. Alternatively, splintingelements 30 and 33 may be comprised of a self dissolving materialwhereby the bladder “plug” is automatically opened over time withoutneed for a retrieval line or string. It is however preferred, forensuring removal, that the splinting element be provided with externallyaccessible retrieval means such as string 31.

It is understood that the above Example and description of the preferredembodiment are exemplary of the present invention and that changes inmaterial, components, structure, method steps and the like may be madewithout departing from the scope of the present invention as defined inthe following claims.

What is claimed is:
 1. A splinting element for facilitating anastomotichealing of a male patient after a radical prostatectomy, comprising: anelongated cylinder having a diameter ranging from about 5 mm to about 10mm, wherein the splinting element is configured to be positioned acrossa urethral opening between a urethra and bladder of the patient, whereinthe elongated cylinder of the splinting element is sized and dimensionedfor positioning across the urethral opening between the urethra andbladder of a male patient, wherein the elongated cylinder is hollow andformed to have an open end and an opposing closed end, wherein thesplinting element further comprises a wing element providing thesplinting element a diameter greater than a diameter of the urethralopening, wherein the wing element is attached to the open end of theelongated cylinder, wherein the splinting element prevents urinedrainage therethrough, and wherein a suture is attached to the wingelement that allows the splinting element to be sutured to an inner wallof the bladder.
 2. The splinting element of claim 1, wherein thesplinting element has a length ranging from about 30 to about 35 mm. 3.The splinting element of claim 1, further comprising a retrieval linehaving a sufficient length to pass through and out of the urethra whenpositioned across the urethral opening, wherein the retrieval line isattached to the closed end.
 4. The splinting element of claim 1, whereinthe wing element is integrally formed with the elongated cylinder. 5.The splinting element of claim 1, comprising an inert material.
 6. Thesplinting element of claim 5, wherein the inert material comprises abio-absorbable material.
 7. The splinting element of claim 1, capable ofbeing used with a separate urine drainage tube.
 8. The splinting elementof claim 1, wherein the open end is configured to be inserted proximateto the bladder relative to the opposing closed end.